A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy +/-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage II, IIIA, and Resectable IIIB (T3-4N2) Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671)
This trial will evaluate the safety and efficacy of pembrolizumab (MK-3475) in combination with platinum doublet neoadjuvant chemotherapy (NAC) before surgery [neoadjuvant phase], followed by pembrolizumab alone after surgery [adjuvant phase] in participants with resectable stage II, IIIA, and resectable IIIB (T3-4N2) non-small cell lung cancer (NSCLC). The primary hypotheses of this study are that neoadjuvant pembrolizumab (vs. placebo) in combination with NAC, followed by surgery and adjuvant pembrolizumab (vs. placebo) will improve: 1) event free survival (EFS) by biopsy assessed by local pathologist or by investigator-assessed imaging using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1); and 2) overall survival (OS).
Inclusion Criteria:
Exclusion Criteria:
Phoenix, Arizona 85004, United States
Newark, Delaware 19718, United States
Basking Ridge, New Jersey 07920, United States
Middletown, New Jersey 07748, United States
Commack, New York 11725, United States
Harrison, New York 10604, United States
Stony Brook, New York 11794-9447, United States
Uniondale, New York 11553, United States
White Plains, New York 10601, United States
Harrisburg, Pennsylvania 17109, United States
Philadelphia, Pennsylvania 19124, United States
Berazategui, Buenos Aires B1884BBF, Argentina
Ciudad de Buenos Aires, Buenos Aires F.D. C1093AAS, Argentina
San Juan, J5402DIL, Argentina
Liège, Liege 4000, Belgium
Brasília, Federal District 70200-730, Brazil
Porto Alegre, Rio Grande do Sul 90610-000, Brazil
Rio de Janeiro, 20230-130, Brazil
Tianjin, Anhui 300052, China
Beijing, Beijing Municipality 100021, China
Shanghai, Shanghai Municipality 200433, China
Ningbo, Zhejiang 315010, China
Pierre-Bénite, Auvergne-Rhône-Alpes 69310, France
Bobigny, Seine-Saint-Denis 93000, France
Koblenz, Rhineland-Palatinate 56073, Germany
Wilton, Cork, Ireland
Milano, Abruzzo 20133, Italy
Meldola, Forli-Cesena 47014, Italy
Kitakyushu, Fukuoka 807-8556, Japan
Poznan, Greater Poland Voivodeship 60-569, Poland
Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-796, Poland
Bystra, Lower Silesian Voivodeship 43-360, Poland
Prabuty, Pomeranian Voivodeship 82-550, Poland
Lodz, Łódź Voivodeship 93-513, Poland
Cluj-Napoca, Cluj 400015, Romania
Cluj-Napoca, Cluj 400015, Romania
Comuna Floresti, Cluj 407280, Romania
Chelyabinsk, Chelyabinsk Oblast 454087, Russia
Saint Petersburg, Sankt-Peterburg 194291, Russia
Saint Petersburg, Sankt-Peterburg 197758, Russia
Kazan', Tatarstan, Respublika 420029, Russia
Parktown-Johannesburg, Gauteng 2193, South Africa
Gyeonggi-do, Kyonggi-do 16247, South Korea
Las Palmas de Gran Canaria, Las Palmas 35001, Spain
Ivano-Frankivsk, Ivano-Frankivsk Oblast 76018, Ukraine
Kropyvnytsky, Kirovohrad Oblast 25006, Ukraine
Zaporizhzhya, Zaporizhzhia Oblast 69040, Ukraine
Metropolitan Borough of Wirral, Liverpool CH63 4JY, United Kingdom